Managing Life-Cycle Reg.Compliance Submissions for Pharma and Medical Devic

Regulation professionals working in the pharmaceutical and medical device sectors, whether in government regulatory departments or private sector companies, must be aware of required regulatory compliance submissions throughout the product life cycle. Students explore guidance documents for the diverse types of pharmaceutical pre-market submissions, post-market pharmacovigilance reporting, and establishment licensing for Good Manufacturing Practices. Students also assess guidance for pre- and post-market submissions for Class II, III and IV medical devices. Finally, students explore the Electronic Common Technical Document (eCTD) submission standard adopted in Canada and other trading partners.